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临床试验/EUCTR2019-000836-24-NL
EUCTR2019-000836-24-NL进行中(未招募)1 期

Immune responses to influenza and pneumococcal conjugate vaccines in older adults compared to middle-aged adults and adults. - VITA

ational Institute of Health and the Environment0 个研究点目标入组 385 人开始时间: 2019年4月30日最近更新:
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相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
385

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Be 25 years or older at the time of inclusion.
  • Have received a seasonal influenza vaccination in previous season (2018-2019).
  • Be capacitated.
  • Have signed Informed Consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 220
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 165

排除标准

  • Having had a previous pneumococcal vaccination (PCV or the 23-valent pneumococcal polysaccharide vaccine (PPV23)).
  • Known or suspected allergy to any of the vaccine components or having experienced a previous severe adverse reaction to any vaccine.
  • Receipt of any high-dose (= 20 mg of prednisone daily or equivalent) daily corticosteroids (local incl. inhaled steroids are acceptable) within 2 weeks of study entry.
  • Repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) in the recent past.
  • Receipt of an organ- or bone marrow transplant
  • Have a (functional) asplenie.
  • Receipt of chemotherapy in the last 3 years.
  • Receipt of blood products or immunoglobulin, within three months of study entry.
  • Known or suspected coagulation disorder that in the opinion of the investigator would contraindicate against receiving an intramuscular injection or undergo frequent blood sampling.
  • Known anemia, measured as Hb < ( 8,5 mmol/l for men and 7,5 mmol/l for woman; NHG standard Anemia)
  • Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis C virus (HCV) and/or hepatitis B virus (HBV).
  • Exclusion criteria COVID-19 vaccination study
  • Treatment with COVID-19 monoclonal antibodies less that 3 months before COVID-19 vaccination.
  • Known pregnancy at the moment of COVID-19 vaccination.

研究者

发起方
ational Institute of Health and the Environment

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